drugset / Trial / NCT05092386

Safety and Immunogenicity Study of a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine

NCT05092386

Phase 1 Completed 310 enrolled Sinovac Life Sciences Co., Ltd.
RandomizedParallel-groupDouble-blindPrevention

Summary

This study is an open-label combined randomized double-blind, positive control phase Ⅰ clinical trial of the a 13-valent Pneumococcal Polysaccharide Conjugate Vaccine manufactured by Sinovac Research \& Development Co., Ltd. The purpose of this study is to preliminary evaluate the safety and immunogenicity of the study vaccine

Timeline

Start
2023-01-03
Primary completion
2024-05-26
Completion
2024-05-28

Drugs

EvaluationDrugModalityDoseRoute
Comparator Pfizer PCV13 Vaccine 0.5 ml
Subject Prevnar 13 Vaccine 0.5 ml
Comparator WALVAX PCV13 Vaccine 0.5 ml